NCT02483780

Brief Summary

The proposed pilot community-based research project will examine the feasibility, acceptability, and potential efficacy of the Storytelling intervention compared with usual care in hypertension control among rural residents in 4 communities in Vietnam. This is a major clinical and public health problem in this developing country.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 6, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

June 22, 2015

Last Update Submit

April 4, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • recruitment rate

    3 months

  • retention rate

    1 year

Secondary Outcomes (1)

  • Blood pressure

    3 months after randomization

Study Arms (2)

Storytelling intervention

EXPERIMENTAL

Two communes will be assigned to intervention group. Within each commune, 25 adults with HTN will be enrolled. Patients will receive 2 DVDs with stories of patients who have successfully controlled their hypertension and "Learn More" section, which will be coordinated with specific patient stories and will fill in gaps not covered by the storytellers.

Behavioral: Storytelling

Usual care

NO INTERVENTION

Two communes will be assigned to usual care group. Within each commune, 25 adults with HTN will be enrolled. Patients will receive 2 DVDs with only didactic material about common non-communicable diseases but without hypertension related stories.

Interventions

StorytellingBEHAVIORAL

The intervention will center on stories about living with hypertension, with patients speaking in their own words.

Storytelling intervention

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Consenting adult men and women must fulfill each of the following criteria:
  • be a resident of the selected commune;
  • be aged 50 years or older;
  • have a diagnosis of hypertension according to the 7th Joint National Commission of High Blood Pressure (JNC 7)
  • not be cognitively impaired (as assessed by study physicians)
  • not be a "story teller" used to develop the intervention;
  • not be a family member of another participant in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Population, Health and Development (PHAD)

Hà Nội, Vietnam

Location

Related Publications (3)

  • Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018.

    PMID: 30596749DERIVED

  • Nguyen HL, Allison JJ, Ha DA, Chiriboga G, Ly HN, Tran HT, Nguyen CK, Dang DM, Phan NT, Vu NC, Nguyen QP, Goldberg RJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial. Pilot Feasibility Stud. 2017 May 1;3:22. doi: 10.1186/s40814-017-0136-9. eCollection 2017.

    PMID: 28473924DERIVED

  • Allison JJ, Nguyen HL, Ha DA, Chiriboga G, Ly HN, Tran HT, Phan NT, Vu NC, Kim M, Goldberg RJ. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial. Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6.

    PMID: 26762128DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hoa Nguyen, MD, Ph.D

    Institute of Population, Health and Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2015

First Posted

June 29, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 6, 2017

Record last verified: 2017-04

Locations

VN(1)